99ACBAMinisterial determination—brand of pharmaceutical item that is not a combination item is not a new brand

#### 99ACBA Ministerial determination—brand of pharmaceutical item that is not a combination item is not a new brand (1) If: (a) a brand of a pharmaceutical item (the trigger item) is not a combination item; and (b) the brand of the trigger item: (i) is not a listed brand of the trigger item; and (ii) is a new presentation of an existing listed brand of a pharmaceutical item; and (c) the Minister is satisfied that the determination day in relation to the brand of the trigger item is to be after the fifth anniversary, and before the tenth anniversary, of the drug in the pharmaceutical item being on F1; the Minister may determine, by notifiable instrument, that the brand of the trigger item is not a new brand for the purposes of section 99ACB. (2) If the Minister makes a determination under this section in relation to the brand of the trigger item, it must be made before the determination day in relation to the brand of the trigger item. (3) In making a determination, the Minister may have regard to: (a) any advice given by the Pharmaceutical Benefits Advisory Committee; and (b) any information provided by the responsible person for the brand of the trigger item; and (c) any other matter that the Minister considers relevant. (4) A determination made under this section ceases to have effect on whichever is the earliest of the following: (a) the day that another brand of the pharmaceutical item becomes a listed brand; (b) the day that the drug in the pharmaceutical item does not satisfy all of the criteria for F1; (c) the tenth anniversary of the drug in the pharmaceutical item being on F1. (5) In this section: > determination day has the same meaning as in paragraph 99ACB(1)(a).